The Effect of Pre-Operative Cryoneurolysis on Post-Operative Narcotic Consumption in Patients Undergoing Autograft ACL Reconstruction

ConditionACL Repair
Trial statusRecruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexAll
Age14+
SponsorVirtua Health, Inc.

About this trial

The purpose of the research is to investigate the effect of preoperative Cryoneurolysis of the knee on postoperative pain management in patients undergoing autograft anterior cruciate ligament (ACL) reconstruction (a surgical procedure that makes a new ACL using the patient's own tendon). Cryoneurolysis is an approved process of applying extreme cold temperatures to targeted nerves in order to decrease or eliminate pain. . If you take part in the research, you will be randomly assigned (assigned by chance, like a flip of a coin) to Group A (standard care) or Group B (standard care plus Cryoneurolysis). Participants in both groups will undergo standard ACL reconstruction and receive standard preoperative and postoperative pain management. Participants in Group B only will also receive a standard treatment of Cryoneurolysis to their surgical knee within 7-10 days before their scheduled surgery. Participants in both groups (A \& B) will be asked to bring their remaining postoperative pain medication to their postoperative follow-up appointments for review by study personnel. Participants will also be asked to complete a survey about their knee activity, function and symptoms at these appointments. Your time in the study will last until the completion of the 12-week postoperative follow-up appointment.

Eligibility criteria

Qualifiers

- Patients aged 14 and over

Patients who are patients within the PI's practice

Patients who can speak and read English

Patients undergoing autograft ACL reconstruction.

Disqualifiers

- Under the age of 14

Non-English speaking/reading patients

Patients with Reynauds' syndrome

Patients with skin disorders or hypo-vascularity

Trial design

Treatments tested in this trial

  • Cryoneurolysis

Treatment groups

20 Participants
are divided into 2 treatment groups

Sponsors and collaborators

Virtua Health, Inc.

Lead sponsor

Pacira Pharmaceuticals, Inc

Collaborator